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510(k) Data Aggregation
(86 days)
Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers.
Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
This document describes the specifications and comparative characteristics of the Elecsys Calcitonin Immunoassay and its associated calibrators and quality controls against predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance (Elecsys Calcitonin Immunoassay vs. Predicate Device)
| Feature | Predicate Device: Immulite 1000 Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay (New Device) |
|---|---|---|
| Intended Use | To measure calcitonin levels in serum for diagnosis and treatment of thyroid and parathyroid gland diseases. | Quantitative determination of human calcitonin in serum and plasma for diagnosis and treatment of thyroid and parathyroid gland diseases (including carcinoma and hyperparathyroidism) in conjunction with other clinical and laboratory findings. |
| Assay Protocol | Solid-phase, enzyme-labeled, two-site chemiluminescent immunometric assay; 2 x 30 minutes incubation, 60 minutes total duration. | Murine monoclonal antibodies (ruthenium complex and biotin labeled) directed against hCT. Streptavidin coated microparticles as solid phase. Sandwich principle. 18 minutes total duration. |
| Detection Protocol | Chemiluminescent Immunometric assay | Electrochemiluminescent Immunoassay |
| Instrument Platform | Immulite 1000 | cobas e 411 |
| Sample Volume | 75 µL | 50 µL |
| Sample Type | Human serum or heparinized plasma | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin, and lithium heparin plasma gel separation tubes. |
| Calibrator | Siemens Calcitonin Adjustors (LCLL, LCLH) | Elecsys Calcitonin CalSet |
| Calibration Interval | Recommended: 4 weeks | Once per reagent lot (fresh reagent, <24 hours since registered on analyzer). Renewed: After 2 months (56 days) for same reagent lot; After 7 days for same reagent kit on analyzer; As required (e.g., QC outside limits). |
| Controls | Two levels (low and high) of calcitonin. | Elecsys PreciControl Varia |
| Traceability/Standardization | Standardized against WHO 2nd IRP 89/620 | Same (Standardized against WHO 2nd IRP 89/620) |
| Reagent Stability | Stable at 2-8°C until expiration date | Unopened: 2-8°C until expiration date. Opened: 2-8°C for 12 weeks. On Analyzers: 4 weeks. |
| Measuring Range | 0.6 - 2000 pg/mL | 1.0 - 2000 pg/mL |
| Precision (Within-run) | Sample 1: 22 pg/mL, 3.9% CVSample 2: 44 pg/mL, 3.0% CVSample 3: 145 pg/mL, 2.3% CVSample 4: 621 pg/mL, 2.2% CVSample 5: 1029 pg/mL, 2.4% CVSample 6: 1207 pg/mL, 2.3% CV | cobas e 411 (Repeatability):0.03 SD @ 1.21 pg/mL3.0% CV @ 11.5 pg/mL2.5% CV @ 48.5pg/mL2.9% CV @ 482 pg/mL2.2% CV @ 1910 pg/mL0.19 SDPCV1 @ 8.88 pg/mL1.5% CVPCV2 @ 97.7 pg/mL |
| Precision (Total/Intermediate) | Sample 1: 22 pg/mL, 11.4% CVSample 2: 44 pg/mL, 7.5% CVSample 3: 145 pg/mL, 7.5% CVSample 4: 621 pg/mL, 10.6% CVSample 5: 1029 pg/mL, 8.5% CVSample 6: 1207 pg/mL, 9.5% CV | (Intermediate):0.04 SD @ 1.21 pg/mL3.6% CV @ 11.5 pg/mL3.5% CV @ 48.5pg/mL4.0% CV @ 482 pg/mL3.4% CV @ 1910 pg/mL0.26 SDPCV1 @ 8.88 pg/mL2.6% CVPCV2 @ 97.7 pg/mL |
| Analytical Sensitivity | 2 pg/mL | Limit of Blank (LoB): 0.3 pg/mLLimit of Detection (LoD): 0.5 pg/mLLimit of Quantitation (LoQ): 1 pg/mL |
| Hook Effect | No high-dose hook effect up to 25,000 pg/mL. | No high-dose hook effect up to 1,000,000 pg/mL. |
| Limitations (Interference) | Hemoglobin < 550 mg/dL, Bilirubin < 200 mg/L, Lipemia < 3000 mg/dL. | Hemoglobin < 200 mg/dL, Bilirubin < 66 mg/dL, Lipemia < 2000 mg/dL, Biotin < 40 ng/mL, Rheumatoid factors < 1,200 IU/mL, IgG < 4 g/dL, IgM < 0.7 g/dL, IgA < 1.6 g/dL. No interference from 17 commonly used and 12 special pharmaceuticals. (Minimizes interference from extremely high titers of antibodies). |
| Method Comparison (Correlation) | n = 150 (Min = 2.04 pg/mL, Max = 1779 pg/mL)Passing/Bablok: Slope 1.01, Intercept -0.404, Tau/r 0.925Deming: Slope 0.998, Intercept -0.305, Tau/r 0.991 | Not explicitly stated as "acceptance criteria", but results are provided for comparison to predicate. |
| Clinical Reference Range (95th/97.5th percentile) | 95th percentile:Female 5.0 pg/mLMale 8.4 pg/mL | 97.5th percentile:Female 7.63 pg/mLMale 14.3 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: n = 150 patient samples were used for the method comparison study against the predicate device.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison or other performance studies. However, the manufacturer is Roche Diagnostics, with establishment registrations in Germany and the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given document. For an in vitro diagnostic device measuring a quantitative analyte like Calcitonin, "ground truth" is typically established by the reference method or by the predicate device's measured values, rather than by human expert review of images or clinical cases.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided for this type of in vitro diagnostic device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as imaging studies, where multiple experts review and reconcile findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and not mentioned for this in vitro diagnostic device. These studies are relevant for medical imaging AI where human readers interpret diagnostic images. The performance of this device is measured through analytical parameters like precision, sensitivity, and method comparison with a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is an in vitro diagnostic immunoassay, meaning its performance is inherently "standalone" in the sense that it analytically measures calcitonin levels. Its performance characteristics (precision, analytical sensitivity, measuring range, etc.) are determined directly by the assay and instrument without a human "in-the-loop" during the measurement process. The results are then interpreted by clinicians. The provided performance metrics (precision, analytical sensitivity, hook effect, method comparison, and interference studies) represent the standalone performance of the assay.
7. The Type of Ground Truth Used
- For the method comparison study, the predicate device's measurements (Immulite 1000 Calcitonin) served as the "ground truth" or reference for comparison. The new device's measurements were correlated against these values.
- For standardization and traceability, both the predicate and the new device were standardized against the WHO 2nd IRP 89/620 (International Reference Preparation) for calcitonin. This international standard effectively acts as the ultimate "ground truth" for calibrating and standardizing calcitonin measurements.
8. The Sample Size for the Training Set
- This document describes performance verification studies, not the development or "training" of an algorithm in the machine learning sense. Therefore, information on a "training set" sample size is not provided and not directly applicable to the described analytical performance studies of a chemical immunoassay.
9. How the Ground Truth for the Training Set Was Established
- As mentioned in point 8, the concept of a "training set" with ground truth in the context of an algorithm or AI is not directly applicable here. For the standardization of the Elecsys Calcitonin Immunoassay, it is stated that the device and its calibrators are standardized to the IRP WHO Reference Standard 89/620. This international reference standard defines the "ground truth" for calcitonin concentration for the purpose of accurate measurement and calibration.
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